FDA Okays Exparel for Postoperative Pain

Megan Brooks

October 31, 2011

October 31, 2011 — The US Food and Drug Administration today approved a novel long-acting nonopioid anesthetic/analgesic for postsurgical pain: bupivacaine extended-release liposome injection (Exparel, Pacira Pharmaceuticals).

Exparel consists of bupivacaine encapsulated in the multivesicular liposome DepoFoam, Pacira Pharmaceutical's extended drug-delivery technology that is the basis for 2 products already on the market: DepoCyte (cytarabine liposome injection) and DepoDur (morphine sulfate extended-release liposome injection).

The new product is designed to extend the duration of analgesia provided by bupivacaine. Based on clinical trial data, Exparel provides continuous and extended postsurgical analgesia for up to 72 hours compared with bupivacaine's analgesic time of 7 hours or less, the company notes.

Exparel has been shown safe in more than 1300 patients across 21 studies, the company says. Most recently, the product was shown to be safe and effective in 2 multicenter, randomized, double-blinded, placebo-controlled, pivotal phase 3 clinical trials in patients undergoing hemorrhoidectomy and bunionectomy.

"Significant Unmet Need"

The company says Exparel addresses a "significant unmet medical need for a long-acting nonopioid postsurgical analgesic." The addition of Exparel to the "armamentarium of postoperative analgesics may reduce the dependence on opioid use in the postoperative setting and delay the time to first opioid use so that oral rather than parenteral opioids can be used," the company explains.

This may lead to improved patient satisfaction and outcomes, minimize breakthrough episodes of pain, and reduce the need for supplemental opioid medications. It may also simplify postsurgical pain management and reduce hospital cost and staff time.

Eugene R. Viscusi, MD, director of acute pain management at Thomas Jefferson University in Philadelphia, Pennsylvania, told Medscape Medical News that this product is "definitely novel, and there is a tremendous need for more nonopioid analgesics as we attempt to limit or reduce opioids because of their side effects and risks. Long-acting agents are particularly desirable because they provide less-complicated, prolonged pain relief for an extended period."

Current local anesthetics, Dr. Viscusi explained, have a duration of action less than the pain duration of most procedures, leading to pain later or to the need for cumbersome indwelling catheter and pump delivery systems for these drugs.

"An extended-release local anesthetic will simplify and improve pain control for many procedures, improve side effects, and reduce some of the burdens and complexities of pump-driven technologies, failures of technology, and resulting analgesic gaps," he explained.

Dr. Viscusi has studied DepoDur and Exparel and has consulted for the companies developing these technologies.


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